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On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.

According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status. The FDA pre-market review process evaluates whether products are safe and effective for their intended use, can be consistently manufactured, and are truthfully and completely labeled.

The decree, filed on FDA’s behalf by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada, prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.

“The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “We believe consumers should be able to trust that the drug products they administer to their pets have been proven to be safe and effective.”

The FDA previously issued a Warning Letter to Garrison regarding Bio Health Solutions LLC’s marketing of RenAvast in August 2012.

Unapproved animal drugs are animal drugs that do not have legal marketing status. They have not been approved, conditionally approved, or indexed by the FDA. In addition, unapproved animal drugs may not meet the agency’s strict standards for safety and effectiveness and may not be properly manufactured or properly labeled. The FDA can take enforcement actions such as issuing Warning Letters to and seeking injunctions against companies that are in violation of the FD&C Act.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

For some 150-200 dogs and a handful of cats in Virginia and Alabama, a second chance at life is just a road trip or flight away. From May 26-30, the American Humane Association, the first national humane organization, will be working with and filming two dramatic transports involving North Shore Animal League America, Pilots N Paws, celebrity animal advocate Beth Stern, philanthropist Lois Pope, and others to save some of the 3-4 million animals relinquished to shelters who are euthanized each year.

On the morning of Tuesday, May 26, one of American Humane Association’s two 50-foot Lois Pope Red Star Rescue vehicles will join a mobile rescue vehicle from North Shore Animal League America at the SPCA of Martinsville, Virginia, where 80-100 dogs will be loaded into the trucks for the drive to North Shore Animal League America’s shelter on Long Island. The dogs will travel in kennels generously donated by the Petco Foundation, who also donated food and water bowls and blankets for these dogs to make the journey as comfortable as possible. Upon arrival in New York, where they will be greeted by celebrity animal advocate Beth Stern (who works with both American Humane Association and North Shore Animal League America), North Shore’s renowned veterinary team will treat the dogs and provide any necessary vaccinations so that the dogs can soon be placed for adoption in forever homes.

Just a few days later on the morning of May 30, the same Lois Pope Red Star Rescue vehicle will travel to Greenville, Alabama, where it will be loaded with another 100 dogs and cats who have been living in local shelters and with foster families. The truck will take them to Mac Crenshaw Memorial Airport where a fleet of 10 private airplanes flown by Pilots N Paws volunteer pilots will meet them and take the dogs to foster families and rescue groups throughout South Florida. American Humane Association will pay for vaccinations and health certificates prior to their flights. Two of these planes carrying 60 dogs will make their way to North Palm Beach Airport, where they will be greeted by a second Lois Pope Red Star Rescue vehicle based in Florida, American Humane Association staff, Beth Stern, and philanthropist Lois Pope herself, who has funded two of the vehicles in the national Red Starfleet. Ms. Stern will be there to take home a mother cat and her five kittens, and foster them at her home in South Florida.

American Humane Association Red Star members will be at the airport to help see that the remaining dogs are placed safely with the local Palm Beach humanitarian group “A Second Chance Puppies and Kittens Rescue,” who will find forever homes for them.

The entire massive coordinated project will be filmed for airing during this fall’s national television broadcast of the 2015 American Humane Association Hero Dog Awards™, presented by the Lois Pope LIFE Foundation, to shine a light on the situation so many animals face. The film will be hosted by Hero Dog Awards co-host, and longtime North Shore League America volunteer, foster parent and national spokesperson Beth Stern. She has also served as a spokesperson for Hallmark Channel.

“For almost 100 years, our Red Star Rescue team has helped rescue and care for animals in difficult situations, and we are honored to help and to take this story to millions so that it may inspire more people to bring a shelter animal into their lives,” said Dr. Robin Ganzert, American Humane Association president and CEO. “Our deepest thanks to everyone who is helping to make this effort possible: North Shore Animal League America, Pilots N Paws, the Petco Foundation, 22 rescue and foster groups, Beth Stern, and, of course, Mrs. Lois Pope, American Humane Association’s light of compassion who has helped us give a second chance to thousands of animals over the years through her generous sponsorship of our Red Star Rescue team, the Hero Dog Awards, and this film.”

“Dogs have always occupied a special place in my heart, and when I learned about the situation in Martinsville and Greenville, I knew we had to do something,” said Mrs. Pope. “I hope this project will inspire many people to adopt more of the millions of animals so they can experience the love and the lives they deserve.”

“We are excited to work in collaboration with the American Humane Association on our latest large-scale rescue to save the lives of nearly 100 animals that might have been euthanized,” said Joanne Yohannan, Senior Vice President of Operations, North Shore Animal League America. “North Shore Animal League America began its humane relocation program over three decades ago and has a long standing relationship with SPCA of Martinsville-Henry County. For the past 20 years we have working together to save the lives of over 20,000 homeless dogs and cats in Virginia and the surrounding area.”

“I’m so excited to be part of this large scale rescue operation that will save the lives of nearly two hundred homeless animals,” said Beth Stern. “I encourage everybody to adopt an animal from their local shelter rather than buying one.”

“It is a life changing experience for me to participate in this combined rescue event,” saidDebi Boies, founder and president of Pilots N Paws. “Working side by side with the American Humane Association’s Lois Pope Red Star team, and numerous rescue organizations, our volunteer pilots are making flights and saving lives. It’s heartwarming to look into the eyes of these precious animals and see that the fear is gone as they head to their new lives.”

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Federal lawmakers today introduced legislation to prevent the establishment of horse slaughter operations within the U.S., end the current export of American horses for slaughter abroad, and protect the public from consuming toxic horse meat. The Safeguard American Food Exports (SAFE) Act, H.R. 1942, was introduced by Reps. Frank Guinta (R-N.H.), Jan Schakowsky (D-Ill.), Vern Buchanan (R-Fla.), and Michelle Lujan Grisham (D-N.M.). The ASPCA® (The American Society for the Prevention of Cruelty to Animals®), the Animal Welfare Institute (AWI), The Humane Society of the United States and The Humane Society Legislative Fund announced their enthusiastic support for the legislation.

Last year, more than 140,000 American horses were slaughtered for human consumption in foreign countries. The animals often suffer long journeys to slaughter plants in Canada andMexico without adequate food, water or rest. At the slaughterhouse, horses are brutally forced into a “kill box” and shot in the head with a captive bolt gun in an attempt to stun them before slaughter—a process that can be inaccurate due to the biology and nature of equines and result in animals sustaining repeated blows or remaining conscious during the kill process.

“For centuries, horses have embodied the spirit of American freedom and pride,” said Rep. Guinta. “To that end, horses are not raised for food – permitting their transportation for the purposes of being slaughtered for human consumption is not consistent with our values and results in a dangerously toxic product. This bipartisan bill seeks to prevent and end the inhumane and dangerous process of transporting thousands of horses a year for food.”

“Horses sent to slaughter are often subject to appalling, brutal treatment,” said Rep. Schakowsky. “We must fight those practices. The SAFE Act of 2015 will ensure that these majestic animals are treated with the respect they deserve.”

“The slaughter of horses for human consumption is an absolute travesty that must be stopped,” said Rep. Buchanan. “This bipartisan measure will finally put an end to this barbaric practice.”

“Horse slaughter is an inhumane practice that causes great pain and distress to the animals, and poses numerous environmental and food safety concerns,” said Rep. Lujan Grisham. “The vast majority of my constituents oppose horse slaughter. I’m proud to support the SAFE Act to ban this cruelty once and for all.”

The SAFE Act would also protect consumers from dangerous American horse meat, which can be toxic to humans due to the unregulated administration of drugs to horses. Because horses are not raised for food, they are routinely given hundreds of toxic drugs and chemical treatments over their lifetimes that are prohibited by the U.S. Food and Drug Administration for use in animals intended for human consumption. Those drugs, although safe for horses, are potentially toxic to humans if consumed. In December 2014, the European Union (EU) announced its suspension of imports of horse meat from Mexico after a scathing audit of EU-certified Mexican horse slaughter plants, which kill tens of thousands of American horses each year. Additionally, the discovery of horse meat in beef products in Europe shocked consumers and raised concerns about the potential impact on American food industries.

The ASPCA, AWI, and The HSUS encourage the public to contact their U.S. representatives and urge them to cosponsor the SAFE Act, H.R. 1942, in order to protect America’s horses and overall consumer health from horse slaughter.

Build-A-Bear (NYSE: BBW), an interactive entertainment retailer of customized stuffed animals, has launched its newest product line —Promise Pets™ — the company’s most realistic pet plush collection to date. The Promise Pets line features a complementary mobile app families can download to bring the experience of pet care to life, teaching children about animal care through an interactive play experience.

Breeds in the collection include the Golden Retriever, Beagle, Yorkshire Terrier and Persian Kitten. Build-A-Bear plans to introduce more breeds throughout the year.

“In line with our strategic product expansion initiative to create play beyond the plush, our Promise Pets interactive app provides a platform to teach children the importance of animal welfare and responsibility for their care,” said Gina Collins, chief marketing officer, Build-A-Bear. “Furthermore, our partnership with Petfinder is a testament to Build-A-Bear’s heritage of supporting animals in domestic pet adoption programs, and underlines our commitment to add a little more heart to life with unique philanthropic collaborations.”

Promise Pets Mobile AppThe Promise Pets mobile app offers children a realistic pet play experience while teaching them about the responsibility of pet ownership. App users will start as ‘Pet Care Rookies’ and work their way up through five levels of certification to earn the ultimate ‘Pet Care Pro’ status. Through fun, engaging games, users will be able to collect Paw Points, earn certificates, and give their pet all the affection and care he or she deserves.

The Promise Pets app will deliver helpful guidance such as:

Feeding: Every pet has different feeding needs, but it is important with any pet to feed it on a schedule, use portion control, provide plenty of water, and provide snacks and treats. Remember, treats should only be used as rewards.

Potty Training: When it comes to potty training your pet, starting as soon as you bring your pet home will help ensure success. Always remember housetraining a dog, cat, or other pet requires a routine and lots of practice.

Vet Checkups: Taking your pet to routine vet checkups is important to help your vet keep a record of your pet’s normal health and behavior, and catch signs of illness as early as possible.

Exercise: Doing daily activities with your pets, such as walking or playing with toys that test their curiosity, can help maintain their physical and mental health.

Grooming: It’s important to keep your pet well-groomed, which for many animals involves regularly bathing, checking for fleas and brushing.

Domestic violence is abhorrent, but what is even more heartbreaking is that many victims delay seeking safe refuge out of concern for what may happen to their pets. Pets are often the voiceless victims of domestic violence abuse or stalking, where abusers target a beloved pet as an attempt to control and terrorize their human victims. Sometimes the pets are brutally harmed or even die as a result of their abusers’ assaults.

Human victims often face the difficult decision of leaving the situation without their pets for their own safety or staying put to ensure that their animal companions get the veterinary care they need should they be harmed. Many survivors have reported delaying leaving an abusive situation out of concern for their pets. Due to the fact a very small percentage of domestic violence shelters nationwide can accommodate pets, sometimes victims are forced to surrender their pets since they are unable to evacuate them, which can deepen the pain and suffering they may already be experiencing.

H.R. 1258 will expand federal law to include protections for pets of domestic violence victims and establish a federal grant program that will help ensure that victims have access to safe shelters for their pets. Specifically, the bill aims to assist both female and male victims with pets by:

making threats to a pet a stalking-related crime;

providing grant funding to increase the availability of housing for victims that accommodates pets;

encouraging states to provide coverage for pets under protection orders; and

requiring abusers who harm pets to pay veterinary and other expenses incurred as a result.

“The PAWS Act represents tremendous advancement in recognition that the abuse of animals in domestic violence threatens the safety and well-being of animals and people alike,” said Maya Carless, an executive director at the Animals and Society Institute. “I have personally worked with hundreds of victims who escaped abusive situations with little more than the clothes on their backs and their pets in their arms. Not only were they struggling to find safety for both themselves and their pets, the abusers’ control over their finances left them unable to afford necessary veterinary care for their pets who had been harmed by the abuse. While many kind-hearted veterinarians help greatly by discounting or donating their services, the PAWS Act would provide financial restitution for the costs of veterinary care in these situations, lifting the burden from the veterinary profession and greatly increasing access to essential veterinary treatment for animal victims of domestic violence.”

The bill, which has been referred to the House Committees on the Judiciary and Agriculture, has 48 original co-sponsors and is supported by numerous local and national domestic violence, animal welfare and professional organizations, including the AVMA. For more information, see Rep. Clark’s press release.

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The U.S. Food and Drug Administration issued an update today on its ongoing investigation into pet illnesses and deaths in animals that ate jerky pet treats. This update includes the latest information about complaints of illnesses, testing findings, and measures taken by the agency to identify the cause of the illnesses and deaths.

As of September 30, 2014, the FDA has received approximately 5,000 complaints of illness associated with consumption of chicken, duck, or sweet potato jerky treats, most of which involve products imported from China. The reports involve more than 5800 dogs, 25 cats, three people, and include more than 1,000 canine deaths.

These numbers include approximately 270 complaints received since the FDA’s last update in May 2014. This is a significant decrease from the previous period (October 2013 to May 2014), in which the FDA had received 1,800 complaints.

Because of the sharp reduction in complaints, the FDA is tentatively planning to shift from a biannual routine reporting cycle to issuing annual updates. This shift in reporting cycles does not mean that the FDA is reducing its effort to investigate the cause of these illnesses: the agency continues to devote significant resources to its investigation, and will post non-routine updates if notable events occur.

Although it is impossible to determine in every case whether the events reported were in fact caused by eating jerky pet treats, the FDA continues to believe that there is an association between some of the reports and consumption of jerky pet treats.

The agency continues to caution pet owners that jerky pet treats are not required for a balanced diet, and encourage them to consult with their veterinarians, both prior to feeding treats and if they notice symptoms in their pets.

The FDA continues to devote significant resources to this investigation and to work with its Vet-LIRN partners to gather and analyze new information as it becomes available. If your pet has experienced signs of illness that you suspect is related to jerky pet treats, please report it to FDA. While FDA does not necessarily respond to every individual complaint submitted, each report is valuable and becomes part of the body of knowledge that helps to inform our investigation.

The animal protection groups had campaigned for three years to end cruel rodeo events, receiving considerable local and regional support. A number of the rodeo’s sponsors had dropped out as a result of the campaign.

“It’s a great victory for animal welfare,” said VHS spokesperson Peter Fricker. “It’s a tribute to the progressive and compassionate people of Vancouver Island.”

VCARE Organizer Melissa de Meulles said “No matter what the reason for the cancellation, this is one less ‎rodeo stop for the animals and hopefully the first of many rodeos to close down. Our community can be proud it spoke loudly and stood up for animals.”

The cancellation of the Luxton Rodeo is the second blow to the rodeo industry in recent years. In 2007, after a long campaign by VHS, the Cloverdale Rodeo announced that it would discontinue four key events: calf-roping, steer-wrestling, team-roping and wild cow milking. VHS also convinced the City of Vancouver to ban rodeos in 2006.

American television icon Bob Barker, best known for hosting CBS’s The Price Is Right from 1972 to 2007, has teamed up with Cruelty Free International to call for an end to cosmetics testing on animals in the United States.

Bob Barker said, “Testing cosmetics on animals is a cruel, outdated, and unnecessary practice. Our nation‘s largest trading partner, the European Union, has banned the sale of animal tested cosmetics and proven it is possible to produce safe cosmetics without harming animals. I am proud to join Cruelty Free International in urging the United States to end cosmetics testing on animals.“

Countless animals suffer in unnecessary outdated and cruel tests for cosmetics. Despite modern alternatives to animal testing becoming increasingly less expensive, faster, and more accurate at predicting human reactions than the antiquated animal tests they replace, there is no national law in place to limit animal testing for cosmetics in the United States.

Ending cosmetics testing on animals in the United States would match progress made elsewhere; the European Union, Norway, Israel and India which have testing bans in place. Additionally, Brazil, New Zealand and South Korea recently made significant strides toward ending animal testing via legislation or policy decisions. Prohibiting animal testing for cosmetics would also reflect the interests of US consumers who, multiple polls show, support ending cosmetic testing on animals.

Cruelty Free International, CEO, Michelle Thew, said:“We are thrilled to have Bob Barker supporting our efforts to see the United States match the progress we have made around the world in ending the use of animals in cosmetics tests. Mr. Barker clearly understands that when one considers the cost in animal lives for cruel cosmetics tests, the price is wrong.”

Cruelty Free International is the only organization solely campaigning for a global ban on animal cosmetics testing. With offices in the UK, US, Brazil and Asia, it works with governments, regulators, companies and partner organizations worldwide and has placed the issue of animal testing on the agenda of many governments for the very first time.

A family’s nonprofit rescue operation for giant-breed dogs won a major ruling Wednesday from the Commonwealth Court that prevents a New Sewickley Townshipfrom using zoning codes to close the shelter and spares more than 20 dogs from likely euthanasia.

Owners Richard and Noreen Kohl can keep Gentle Ben’s Giant Breed Dog Rescue open thanks to pro bono representation from McGuireWoods. The firm defended the Kohls against complaints of a neighbor and the township’s claim that Gentle Ben’s is a commercial kennel operating in a residential area in violation of zoning codes.

“This ruling establishes the very important principle that municipalities cannot classify non-profit rescues as kennels and zone them out of communities where they are providing such a critical need,” said Matt Monsour, an associate in McGuireWoods’ Pittsburgh office who represented the family.

“In Pennsylvania, non-profit rescues can now do what they do best: save neglected, unwanted, and abused dogs without fear that their good deeds will subject them to the kennel bar,” said Monsour, whose commercial litigation practice ranges from counseling clients in amicable dispute resolutions to lawsuits in federal and state courts nationwide.

The Kohls had operated a rescue for 20-40 dogs typically of 100 pounds or more on their fenced-in property for 11 years. They are licensed by the Pennsylvania Department of Agriculture as a nonprofit kennel, dependent on donations and adoption fees to cover expenses.

The case dates to September 2012 when William and Barbara Layton, neighbors living adjacent to Gentle Ben’s, complained of barking dogs on the Kohls’ two-acre property. A zoning officer told the applicants that a kennel was not a permitted use under township zoning regulations.

In December 2012, they sought a variance from the township’s Zoning Hearing Board to run a nonprofit dog rescue shelter. In 2013, after January and March hearings, the board ruled in April that although the rescue service was commendable, it was an unpermitted kennel and declined to grant a variance.

The Kohls appealed to Beaver County Common Pleas Court, which found that Gentle Gen’s was a nonprofit that realized no economic gain for its owners, was not a commercial kennel for zoning purposes and reversed the zoning board’s ruling. The Laytons appealed and the Commonwealth Court’s three judges on Wednesday affirmed the lower court decision, rejecting the Laytons’ argument that the trial court’s definition of a kennel was too narrow.

McGuireWoods LLP is a leading international law firm with nearly 1,000 lawyers in 20 offices worldwide. For more information, visit www.mcguirewoods.com. Its full-service public affairs arm, McGuireWoods Consulting LLC, offers infrastructure and economic development, strategic communications and grassroots, and government relations solutions.

Therapy dogs may improve the emotional well-being of some cancer patients, according to results of a clinical study, the first to document the benefits of animal-assisted therapy in adult cancer patients. The research was made available this week in the Journal of Community and Supportive Oncology.

The study, conducted by researchers at Mount Sinai Beth Israel, found that patients receiving intensive multi-modal concomitant radiation therapy and chemotherapy for gastrointestinal, head or neck cancers experienced increases in emotional well-being and quality of life when they received visits from a certified therapy dog during the course of their treatment. Increases in emotional well-being were significant over the course of the animal-assisted visits, even as patients underwent marked and significant declines in both physical and functional well-being. The research was supported by The Good Dog Foundation, the leading provider of professionally trained, fully certified and supervised volunteer therapy dog teams; Zoetis, a leading global animal health company; and the Pfizer Foundation.

“This study is the first such definitive study in cancer, and it highlights the merits of animal- assisted visits using the same scientific standards as we hold for the cancer treatment itself. It shows the importance of an innovative environmental intervention during cancer treatment,” said Stewart B. Fleishman, MD, principal investigator and Founding Director of Cancer Supportive Services at Mount Sinai Beth Israel. “Having an animal-assisted visit significantly improved their quality of life and ‘humanized’ a high-tech treatment,” he said. “Patients said they would have stopped their treatments before completion, except for the presence of the certified Good Dog Foundation therapy dog and volunteer handler.”

An Emerging Role for Animal-Assisted Therapy

Identification of a creative tool to boost patients’ emotional state, especially in face of the high symptom burden for patients receiving concurrent radiation therapy and chemotherapy, underscored the value of an intervention that can be offered in cancer centers nationally and internationally.

“Thanks to this rigorously designed study, we now have strong evidence that pet therapy is an effective tool to help cancer patients get through challenging treatments,” said Gabriel A. Sara, MD, Medical Director, Infusion Suite at Mount Sinai Roosevelt, and Assistant Clinical Professor of Medicine, Icahn School of Medicine at Mount Sinai.

“There is mounting evidence in human and veterinary medicine that the emotional bond between people and companion animals can have a positive impact of emotional and physical health,” said J. Michael McFarland, DVM, DABVP, Zoetis group director of Companion Animal Veterinary Operations. “These new results help advance our understanding of the value of animal-assisted therapy in cancer treatment and point to the ways the oncology and animal health communities can work together in supporting cancer patients achieve the best possible treatment outcomes.”

Rachel McPherson, Executive Director and Founder of The Good Dog Foundation added: “We are excited to see the results of this peer-reviewed study, which bears out scientifically what we have seen for more than sixteen years at The Good Dog Foundation, which is that highly trained and fully certified therapy dogs can provide critical healing services to help change cancer patients’ experiences for the better as they receive treatment.”

Study Details

The study assessed the impact of certified therapy animal-assisted visits on quality of life during multi-modal treatment for head and neck and gastrointestinal cancers using a validated and reliable quality of life assessment routinely used in cancer clinical trials.

Forty-two adult patients were enrolled and 37 patients (25 male; 12 female) completed the six- week study, receiving daily 15-to-20-minute animal-assisted visits. The patients had aggressive cancers in the head and neck, and chose rigorous combined chemotherapy and radiation therapy in advance of a smaller than otherwise planned surgery.

Many traveled to Mount Sinai Beth Israel for 30 radiation therapy treatments in addition to scheduled chemotherapy. They were extremely fatigued, frightened and lost weight vital to maintain their strength. Many had feeding tubes, lots of mucus in the mouth and throat and temporarily lost their senses of smell and taste.

Assessments included FACT-G scale were made at baseline, week 3, and end of therapy (7 weeks). Satisfaction with assisted animal visit (AAV) Intervention assessed ability to withstand treatment, lingering effect of AAV after treatment and perception of social support.

The 37 patients completed at least baseline and one follow-up assessment for a single group analysis of change over time. Patients underwent marked and significant declines in terms of both physical well- being (overall p < 0.001) and functional well-being (overall p = 0.003).

A similar decline in emotional well-being over that period would have been expected with the cumulative side-effect burdens of treatment. Instead, social well-being showed an increase (overall p = 0.03; p baseline versus week 3 = 0.02; baseline versus week 7, p = 0.04).The means for emotional well-being also showed small increases over time, which were not significant when time was analyzed by itself. After controlling for declines in physical well-being at each time point, the increases in emotional well-being were both statistically significant (overall p- value = 0.004) and clinically meaningful.

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